The import of medical products for the purpose of state registration is defined by the regulation of the health department of the Russian Federation no. 7 of June 15, 2012.

For importing medical devices in the Russian Federation, authorization has to be obtained in advance. The approval is granted by the Federal Authority of health control Roszdravnadzor. The authorization is valid until 6 months after the date of issue.

The following documentations are required to apply for an import license:

  • Application with following indications:
    • product specification with components, quantity, manufacturing number, serial number, manufacturing date, lifetime
    • scope of application of the medical products
    • name of the manufacturer, address, legal form, registry number
    • name and address of the testing laboratory
  • Copy of the contract with the testing laboratory, that will conduct the tests
  • Authorization of the representative

All documents have to be presented in Russian. Documentations in German or English have to be translated. The translation has to be certified by a notary.

Schmidt & Schmidt supports you importing medical products and their following state registration. Please send us a request for further details about the procedure and the prices.

Your benefits

Our most important concern is the individual approach for each client as well as complete transparency and high quality of our services.

  • Fast processing of requests and orders
  • In-depth knowledge of legal frameworks
  • Established cooperation with bodies designated by the state
  • Free delivery of EAC certifications
  • Availability of your technical documentation for supervisory and regulatory authorities
  • Confidentiality and secrecy

Our goal is to establish a mutually beneficial business relationship with all of our clients and partners.

Please call us or send us an email. We will provide you with a free, non-binding quote and will be glad to answer all your questions about import of medical products in Russia and the EAEU. Convince yourself of the quality of our services!

In our video, we explain what an EAC Certification is and how and where to certify or declare your products for the introduction on the EAEU market.

The EAC Certification and the EAC Declaration are complex procedures that attest your products the conformity with the technical regulations of the EAEU and require a lot of know-how. Schmidt & Schmidt will support you with the certification of your products for the EAEU market.


The rules on certification in Russia and the EAEU change frequently. We are committed to keeping you up to date with the regulatory requirements even after our cooperation. For this purpose, we offer you the option of subscribing to a newsletter that will keep you reliably informed of any changes.

All personal Data of the user are stored exclusively for the delivery of newsletters. The consent is revocable at any time under, which leads to a deletion of the collected user data. The data will only be stored as long as they are needed for the purpose mentioned. For more information see our Privacy Policy.
SEPA Bank Transfer

Qualified team of experts and consultants

Our experts have many years of experience in export and certification

Certification of all product types

We work with clients from all branches of industry

Quick processing of orders

We handle client's needs individually and process the requests quickly

Profound knowledge of technical regulations

Due to our technical and legal know-how, we guarantee high quality of services

Free delivery of documents

Your documents will be provided free of charge in the shortest possible time